1. Field of the Invention
The present invention generally relates to condom articles and to method and apparatus for making and using the same.
2. Description of the Art
In recent years, there has been a significant increase in the incidence and spread of sexually transmitted diseases, and this phenomenon has in turn caused an increased use of condoms as a prophylactic measure to reduce the risk of infection and transmission of such diseases.
Among the reasons for the increase in incidence and rate of transmission of sexually transmitted diseases (STD's) are the development of increasingly antibiotic-resistant strains of disease-causing organisms, e.g., those responsible for diseases such as syphilis and gonorrhea. Another factor has been the absence of any effective cure for acquired immunodeficiency syndrome (AIDS).
Recent disclosures by the Centers for Disease Control (Washington and Atlanta), and reports at the Third International AIDS Conference in Washington, D.C. in June, 1987, have focused international attention on the proliferation of acquired immunodeficiency syndrome (AIDS) in the general population, beyond the originally defined high-risk classification groups of homosexuals, bisexuals, intravenous drug users, and Haitian/African groups.
The diseases with which AIDS has been or is suspected to be linked include Pneumocystis carinii pneumonia, Kaposi's sarcoma, esophageal or bronchopulmonary candidiasis, extrapulmonary cryptococcoses, cytomegalovirus internal organ infection, disseminated Mycobacterium avium complex or M. Kansasii infection, chronic herpes simplex ulceration, chronic cryptosporidiosis enteritis, toxoplasmosis of the brain, high-grade B-cell non-Hodgkin's lymphoma, disseminated histoplasmosis, chronic isosporiasis enteritis, and lymphoid interstitial pneumonia in children.
In a recent San Francisco cohort study reported in "AIDS: The Cost in Health and Lives," Selik, M. D. Richard M., et al, The Internist, April, 1987, p.p. 6 et seq., there was found to be, for every case of AIDS in the group studied, nine cases of other HIV-related morbidity. As also indicated in this article, cohort follow-up studies indicate that the proportion of HIV-infection persons who will ultimately develop AIDS ranges from 25% to 50% or more depending on the length of follow-up and the patient's clinical status at the beginning of the study. Mathematical modeling of this trend in reported AIDS cases has led to a projection that the cumulative total of AIDS cases will be 270,000 by 1991, and the number reported that year alone be 74,000.
Against the foregoing background, and the recognition that condoms afford a safe, low cost, and generally reliable means for combating the spread of STD's, including AIDS, there has been an increased demand for condoms.
Currently, most condoms are produced from a latex resin via dipping process in which a cylindrical and rounded-end mold is dipped into a resin bath, so that the mold is coated with a thin layer of the latex material. The thickness of the latex coating on the mold is dependent on the viscosity of the latex, and the speed of extracting the mold from the latex bath. Similar latex dipping processes have been employed with suitably shaped molds to form tight-fitting gloves such as surgical gloves.
The above-described latex resin dipping process has been utilized for decades, and yields a generally satisfactory barrier product at reasonable cost.
With the recent spread of AIDS in the general population and the resurgence of condom usage in sexual activities, there has been interest in improving the strength and reliability characteristics of condoms, and of achieving improvements in manufacturing processes, and economics, to further combat the spread of STD's generally, AIDS specifically, as well as to provide a safe and reliable contraceptive means.
U.S. Pat. No. 4,576,156 issued Mar. 18, 1986 to Manfred F. Dyke discloses a condom formed of a thermoplastic polyurethane material, having a generally cylindrical configuration with an open proximal end and a closed distal end. The disclosed condom has a thickness of from about 0.01 millimeters, or less, to about 0.25 millimeters. The thermoplastic polyurethane employed to form the condom is disclosed as having: an average Shore A hardness of from about 50 to abut 90; a tensile stress, at 100% of elongation, between about 300 and 1,000 psi; and a tensile stress, at 300 elongation, between about 800 and 3,000 psi. Suitable thermoplastic polyurethane species for manufacturing the condom include those set out at column 2, line 55 to column 3, line 10 of the Dyke patent, with polyether- or polyester-based urethane elastomers said to be preferred. In the manufacture of the thermoplastic polyurethane condom disclosed in the Dyke patent film of the polyurethane material, e.g., in the form of a 6-inch square, is heated to a temperature high enough to soften the polymer but low enough to PG,5 avoid chemical degradation, preferably in a clamping frame, and at a temperature of about 400.degree.-500.degree. F. The heated film then is brought into contact with a preformed mandril to cause the film to assume the shape of the mandril, preferably with application of a vacuum to the system in order to bring about uniformity in wall thickness (column 3, lines 47-50 of the patent).
European patent application 0 147 072 published Jul. 3, 1985 in the names of Robert A. Taller, et al, discloses a process for making a polyurethane condom with a uniform thickness of from about 1.5 to about 4 mils. A heat cured polyurethane prepolymer solvent solution is employed into which a mold is dipped and withdrawn for heat curing on the mold. The polyurethane prepolymer which is employed in the dipping medium is a prepolymer which is the reaction product of a polyisocyanate with at least one long chain polyol. The polyol is amorphous at room temperature, has an average molecular weight of from about 500 to about 5,000, a hydroxy number of from 225 to about 22.4, and a NCO/OH ratio of from about 0.95:1 to about 1.1:1.
U.S. Pat. No. 4,009,717 to C. H. Allen discloses a condom comprising inner and outer sheaths, with the inner-sheath volume providing a fluid reservoir so that the interior of the inner sheath remains dry. The outer sheath is closed at one end and at the other. The inner sheath is open at both ends inside the outer sheath, with means between the inner and outer sheath establishing a fluid-tight seal to form a fluid reservoir therebetween.
U.S. Pat. No. 4,232,675 to E. N. Meldahl discloses a modified condom of shorter length than conventionally employed, interiorly containing a spermicidal ring and a penis-supported harness assembly.
Various condom designs have been evolved which feature a double-walled chamber at the distal end of the condom containing contraceptive or medicant material. Examples include U.S. Pat. No. 4,332,243 to M. Gutnick; U.S. Pat. No. 2,410,460 to J. P. Robinson; U.S. Pat. No. 4,446,860 to M. Gutnick; and U.S. Pat. No. 2,577,345 to F. L. McEwen.
West German Offenlegungsschrift 2020280 discloses a condom comprising two sheaths inserted in each other, the inner sheath having an opening through which semen can discharge and which is fastened in place by two rubber rings.
U.S. Pat. No. 2,433,538 to H. W. Warner discloses a sperm receptacle article comprising a receptacle member having a removable container therein. The container comprises a distal receiver opening and contains absorbent material for receiving and absorbing the sperm specimen. This patent states, at column 3, lines 3-9, that sperm passes directly from the wearer through the receiver opening into the absorbent material in the removable container. It is apparent from this description that the receptacle member is placed on the male organ and the distal end of the penis is in the vicinity of the proximal wall of the sperm container, but that the penis is not inserted through the sperm container opening.
U.S. Pat. No. 2,586,674 to F. Lonne describes a prophylactic construction (see FIG. 3 of the patent, and appertaining description at column 2, lines 26-36) wherein a double-layer condom comprises an inner pellicle having annular projections or extensions transverse to the longitudinal dimension of the prophylactic.
U.S. Design Pat. No. 253,009 to T. Okamoto shows a prophylactic device whose frontal (distal) section comprises a pair of indented surface portions forming circumferential grooves in the prophylactic, transverse to the longitudinal axis thereof.
U.S. Pat. No. 3,295,145 to R. E. Erickson describes a urine collector for infants, comprising front and rear panels peripherally sealed to one another. The panels are also sealed to one another by inclined seams, extending from the outer periphery downwardly and inwardly for part of the distance to the center line of the collector, to form a throat dividing the collector into upper and lower compartments. The back panel of the collector features an oval aperture having its major axis aligned with the longitudinal axis of the collector, to accommodate the external genitals of a small child. Surrounding the aperture is a pressure sensitive adhesive for adhering the collector to the infant's skin. The patent teaches, at column 2, lines 62-65, that the collector panels preferably are formed of a substantially transparent thermoplastic film such as polyethylene, vinyl copolymers and the like, preferably form about 0.5 to 3 mils in thickness.
U.S. Pat. No. 4,022,213 to D. Stein discloses a male drip urinal comprising a tubular sleeve provided with a thin rubber sheath adapted to be stretched over the penis for sealing purposes, with an apertured resilient sheet provided across the mouth of the urinal sleeve for sealing about the base of the penis. The purpose of this sheet, which extends radially from the mouth of the urinal, is to provide a backup seal should the inner sheath tear. The sheet is carried by an annular ring forming the mouth of the urinal sleeve. The patent states at column 2, lines 8-16 that the sheet or diaphragm is in the form of a rubber disk of approximately 1/8 inch thickness having a central hole of approximately 7/8 inch diameter for sealably engaging the base of the penis, to prevent backup of urine through the mouth of the sleeve and onto the wearer's clothing.
U.S. Pat. No. 2,448,938 to A. Wayne describes a sanitary protective appliance which may, as shown in FIGS. 5 and 6 of the patent, be configured with a shield-like body portion which is a slightly convex shape in side elevation view, with an accordion-like finger portion which is foldable back against the convex of the body portion. The finger portion is convergingly shaped from its proximal to its distal end portions. The body portion of this device contains a generally central opening forming a passage into the finger portion and comprises an integral tab to facilitate removal of the appliance after use. The rear (proximal) face of the body portion is peripherally coated with an adhesive coating material, except for the tab. The adhesive coating is overlayed with a gauze cover which is removable to affix the appliance, for covering or protecting a body appendage. The patent discloses that the accordion finger and body portion may be round or oval in cross-section, depending on the shape of the appendage on which it is to be used. The patent states, at column 3, lines 8-15, that the appliance comprising the body portion and finger-like portion "provide a protective cover for a suitable body appendage with the finger like portion providing an additional receptacle or secondary tip capable of holding puss or other extraneous matter away from the body."
U.S. Pat. No. 4,735,621 to L. Hessel discloses a tubular protective condom-like device comprising a flexible, thin-walled tube that is closed at one end and has at an opposite open end a collar-shaped, outwardly extending portion with means for radially stretching the collar or open end. In one disclosed embodiment, the device has a first outwardly extending ring-shaped means adapted for radially extending the open end, and a second outwardly extending ring-shaped means that is adapted for radially extending the closed end. The second ring-shape means thus secures or maintains the device in the vagina in a manner similar to a diaphragm. The inner diameter of the device is sufficiently large to permit movement of a penis during coital contact.
It is an object of the present invention to provide improved condom articles which are readily, simply, and inexpensively formed.
It is another object of the invention to provide apparatus and methods for making and using condoms of such types.
Other objects and advantages of the present invention will be more fully apparent from the ensuing disclosure and appended claims.